Data / Medical devices / United States / IPB Inc
IPB Inc: FDA-registered device maker in Ogden, UT, United States, 2 510(k) clearances
IPB Inc is registered with the FDA (registration 3003618527) in Ogden, UT, United States. It lists 13 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 6, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003618527
- Address
- 2835 Commerce Way, Ogden, UT, United States, 84401
- Owner or operator
- IPB Inc (10029225)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- May 28, 2013
- Registered through
- 2026
- Brand names listed
- Dental Wax, Evacuator, Floss, Dental, Mouth Mirror
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Retractor, Dental | EIF | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Specification developer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Specification developer | accessdata.fda.gov |
| Attachment, Precision, All | EGG | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Evacuator, Oral Cavity | EHZ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Contract manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Manufacturer | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Contract manufacturer | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Specification developer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Specification developer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 6, 2022 | K220612 | PrimeLOC Attachment System | NHA | Substantially Equivalent | Innovative Product Brands, Inc. | accessdata.fda.gov |
| July 28, 2015 | K151150 | Elements | ELW | Substantially Equivalent | Pac-Dent International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wax, Dental, Intraoral
- All makers of Mirror, Mouth
- All makers of Pick, Massaging
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Evacuator, Oral Cavity
- All makers of Dam, Rubber
Updated June 6, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.